# K241611: ShapeIT (SI014135)

- Pathway: 510(k) (Traditional)
- Applicant: Imds Operations B.V.
- Decided: Sep 3, 2024 after 90 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931794 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223728: Micro Rx, Imds Operations B.V. (2023) Summary page 5.

## Indications for use
The ShapeIT catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature. The device is contraindicated for use in the neurovasculature.

Source page: https://510kreport.com/device/K241611
Methodology: https://510kreport.com/methodology